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Buccal Plate Expansion Technique Versus Guided Bone Regeneration Technique in Socket Preservation in the Aesthetic Zone.

Primary Purpose

Bone Resorption After Tooth Extraction

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Buccal plate expansion technique for dental socket preservation
Guided bone regeneration technique for post-extraction dental socket preservation
Sponsored by
Passant Khaled Tayaa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bone Resorption After Tooth Extraction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients requiring tooth extraction in the maxillary anterior teeth and premolars ranging to the second premolar.
  • Cause of tooth extraction is due to caries, trauma or failed endodontic treatment.
  • Only teeth with intact buccal bone plate will be considered for this study.
  • Patients who are cooperative, motivated and hygiene conscious.
  • Patients whose age is >18 years

Exclusion Criteria:

  • Systemic conditions/disease that contraindicated surgery.
  • Patients on drugs that may compromise bone healing.
  • Radiation therapy in the head and neck region or chemotherapy during the 12 months prior to surgery.
  • Smokers.
  • Patients with Psychologic disorder.
  • Pregnancy or lactation.
  • Presence of acute periodontal or periapical pathology.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Other

    Arm Label

    Buccal plate expansion technique in dental socket preservation

    Guided Bone regeneration technique for socket preservation

    Arm Description

    An internal osteotomy of the socket buccal plate will be performed with a piezotome (SurgyStar). Two vertical osteotomies and one horizontal osteotomy will be made to push the buccal plate outward from the socket. Two small cervical releasing incisions will be made in the mesiobuccal and distobuccal aspects of the socket to permit the displacement of the osteotomies in the area of keratinized tissue. The socket will be loaded with natural bovine bone mineral (cerabone). The biomaterial will be pressed to push the released buccal plate outward. A collagen bio absorbable membrane will be utilized to cover the socket. The collagen membrane plug will be stabilized on the top of the socket with a cross suture (silk 4/0).

    On buccal side, two vertical incisions will be made at mesial and distal papilla of the adjoining teeth. These incisions will be stretched out past mucogingival junction. After full-thickness flap reflection on buccal and lingual sides, atraumatic tooth extraction utilizing periotome will be performed. The periosteum of buccal flap will be incised; this would permit coronal advancement of facial flap and a tension-free primary closure. Extraction sockets will be grafted with natural bovine bone mineral (cerabone). Collagen membrane will be trimmed and placed on the grafted socket and alveolar bone. Buccal and lingual/palatal flaps will be approximated utilizing interrupted simple loop and vertical mattress sutures (4/0) (Sadeghi et al., 2016).

    Outcomes

    Primary Outcome Measures

    measuring horizontal and vertical bone dimensions 4 months after the surgical intervention.
    measuring the horizontal and vertical bone loss after socket preservation using cone beam computed tomography (CBCT).

    Secondary Outcome Measures

    Full Information

    First Posted
    February 11, 2017
    Last Updated
    February 22, 2017
    Sponsor
    Passant Khaled Tayaa
    Collaborators
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03065803
    Brief Title
    Buccal Plate Expansion Technique Versus Guided Bone Regeneration Technique in Socket Preservation in the Aesthetic Zone.
    Official Title
    Clinical Assessment of Buccal Plate Expansion Technique Versus Guided Bone Regeneration Technique in Socket Preservation in The Esthetic Zone: A Randomized Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 1, 2017 (Anticipated)
    Primary Completion Date
    January 2018 (Anticipated)
    Study Completion Date
    May 1, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Passant Khaled Tayaa
    Collaborators
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Introduction and evaluation of a new technique for socket preservation involving internal expansion of the buccal plate of the extraction socket using internal flapless corticotomy and bone grafting the extraction socket with application of bioresorbable membrane biomaterials in comparison with the conventional guided bone regeneration technique for a conventional socket preservation method hoping to maintain or improve hard and soft tissue contour of the alveolar ridge post tooth extraction.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bone Resorption After Tooth Extraction

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Buccal plate expansion technique in dental socket preservation
    Arm Type
    Active Comparator
    Arm Description
    An internal osteotomy of the socket buccal plate will be performed with a piezotome (SurgyStar). Two vertical osteotomies and one horizontal osteotomy will be made to push the buccal plate outward from the socket. Two small cervical releasing incisions will be made in the mesiobuccal and distobuccal aspects of the socket to permit the displacement of the osteotomies in the area of keratinized tissue. The socket will be loaded with natural bovine bone mineral (cerabone). The biomaterial will be pressed to push the released buccal plate outward. A collagen bio absorbable membrane will be utilized to cover the socket. The collagen membrane plug will be stabilized on the top of the socket with a cross suture (silk 4/0).
    Arm Title
    Guided Bone regeneration technique for socket preservation
    Arm Type
    Other
    Arm Description
    On buccal side, two vertical incisions will be made at mesial and distal papilla of the adjoining teeth. These incisions will be stretched out past mucogingival junction. After full-thickness flap reflection on buccal and lingual sides, atraumatic tooth extraction utilizing periotome will be performed. The periosteum of buccal flap will be incised; this would permit coronal advancement of facial flap and a tension-free primary closure. Extraction sockets will be grafted with natural bovine bone mineral (cerabone). Collagen membrane will be trimmed and placed on the grafted socket and alveolar bone. Buccal and lingual/palatal flaps will be approximated utilizing interrupted simple loop and vertical mattress sutures (4/0) (Sadeghi et al., 2016).
    Intervention Type
    Procedure
    Intervention Name(s)
    Buccal plate expansion technique for dental socket preservation
    Other Intervention Name(s)
    Internal corticotomy for buccal plate of bone in extraction socket for socket preservation
    Intervention Description
    An internal osteotomy of the socket buccal plate will be performed with a piezotome (SurgyStar). Two vertical osteotomies and one horizontal osteotomy will be made to push the buccal plate outward from the socket. Two small cervical releasing incisions will be made in the mesiobuccal and distobuccal aspects of the socket to permit the displacement of the osteotomies in the area of keratinized tissue. The socket will be loaded with natural bovine bone mineral (cerabone). The biomaterial will be pressed to push the released buccal plate outward. A collagen bio absorbable membrane will be utilized to cover the socket. The collagen membrane plug will be stabilized on the top of the socket with a cross suture (silk 4/0).
    Intervention Type
    Procedure
    Intervention Name(s)
    Guided bone regeneration technique for post-extraction dental socket preservation
    Intervention Description
    After full-thickness flap reflection on buccal and lingual sides, atraumatic tooth extraction utilizing periotome will be performed.The periosteum of buccal flap will be incised; this would permit coronal advancement of facial flap and a tension-free primary closure. Extraction sockets will be grafted with natural bovine bone mineral (cerabone). Collagen membrane will be trimmed and placed on the grafted socket and alveolar bone.. Buccal and lingual/palatal flaps will be approximated utilizing interrupted simple loop and vertical mattress sutures (4/0)
    Primary Outcome Measure Information:
    Title
    measuring horizontal and vertical bone dimensions 4 months after the surgical intervention.
    Description
    measuring the horizontal and vertical bone loss after socket preservation using cone beam computed tomography (CBCT).
    Time Frame
    4 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients requiring tooth extraction in the maxillary anterior teeth and premolars ranging to the second premolar. Cause of tooth extraction is due to caries, trauma or failed endodontic treatment. Only teeth with intact buccal bone plate will be considered for this study. Patients who are cooperative, motivated and hygiene conscious. Patients whose age is >18 years Exclusion Criteria: Systemic conditions/disease that contraindicated surgery. Patients on drugs that may compromise bone healing. Radiation therapy in the head and neck region or chemotherapy during the 12 months prior to surgery. Smokers. Patients with Psychologic disorder. Pregnancy or lactation. Presence of acute periodontal or periapical pathology.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Passant Khaled
    Phone
    20201005533777
    Email
    dr.passant.khaled@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    the data will be available for other scientists after the end of the study on www.clinicaltrials.gov , all data will be shared except patient contact or private data

    Learn more about this trial

    Buccal Plate Expansion Technique Versus Guided Bone Regeneration Technique in Socket Preservation in the Aesthetic Zone.

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